The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0860-2022·Announced 2022-05-18

Esomeprazole magnesium delayed-release capsules recalled for impurity specification failure

Mylan Institutional Inc. is recalling Esomeprazole Magnesium Delayed-Release Capsules 20 mg due to failed impurity specifications detected during stability testing. 555 cartons of affected lots were distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves failed impurity specifications and represents a risk-of-harm product. With no reported illnesses or injuries and per the rubric criteria, this is classified as High severity.

Plain-English summary

Mylan Institutional Inc. (d.b.a. UDL Laboratories) is recalling Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in unit dose blister cards of 6 (10 cards per carton). The product is manufactured for Mylan Pharmaceuticals Inc. and was distributed nationwide within the United States.

The recall was initiated because impurity levels exceeded acceptable specifications during stability testing at the 12-month room temperature time point. Out-of-specification results were detected for any other individual impurity.

The affected lots include: 3112743 (expiration 4/30/2023), 3112582 (expiration 3/31/2023), 3110438, 3111708, and 3111120 (expiration 7/31/2022). A total of 555 cartons were distributed.

The recalled product

Product
Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-009-16
Manufacturer
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Category
Drug
Hazard
Affected units
555

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Lot #: 3112743
  • Exp. Date 4/30/2023
  • 3112582
  • Exp. Date 3/31/2023
  • 3110438
  • 3111708
  • 3111120
  • Exp. Date 7/31/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories) under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

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Same hazard · impurity exceedance

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